This is a multicenter, prospective, specimen collection study for development and evaluation of tests used to detect endometrial cancer, other cancers, or their causes.
Age ≥ 45 years, OR age ≥ 18 years with at least one risk factor
Diagnosed with abnormal uterine bleeding (AUB)
Planning standard-of-care endometrial tissue sampling to assess for endometrial cancer (EC) or atypical endometrial hyperplasia/endometrial intraepithelial neoplasia (AEH/EIN)
Age ≥ 18 years
Prior partial or complete hysterectomy
Current pregnancy
Prior pelvic or vaginal radiotherapy
Chemotherapy within past 5 years (except tamoxifen)
Patients receiving routine clinical care within participating primary care, gynecology, oncology, and Veterans Affairs health systems across rural, urban, and suburban regions of the United States.
Cohort
Prospective
Not listed
Collection of clinically characterized vaginal fluid specimens
Vaginal fluid specimens will be collected during a standard clinical exam using a swab-based collection method. Specimens will be used for research purposes to support the development of biomarker assays. No specific biomarkers or analytical methods are defined as part of this study.
Clinical data for biomarker assay development and evaluation
Clinical information will be collected as part of routine study participation and used to describe the study population and support research analyses. Data will be used in aggregate to contextualize research findings and inform future assay development.
Collection devices for detection
Specimens will be collected using swab-based collection devices intended solely for specimen collection. These devices do not provide diagnostic results and are not used for clinical decision-making.
Characterization of endometrial neoplasia, other neoplasms, or underlying causes
Characterization will be based on existing clinical assessments and diagnoses obtained through standard medical care. The study does not establish diagnostic criteria or endpoints and is intended for research and development purposes only.
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